MAUDE Adverse Event Report: FEMCARE - NIKOMED LTD. FILSHIE CLIPS; LAPAROSCOPIC CONTRACEPTIVE TUBAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Headache (1880); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Abdominal Cramps (2543); Confusion/ Disorientation (2553); Heavier Menses (2666)

Event Type  Injury  

Event Description

Filshie clips were used without my knowledge almost 6 years ago.Since then i have had headaches, sharp pains and cramping in the abdomen, lower back pain, brain fog and memory problems to name a few symptoms.I only found out i had the clips when i went to have an x-ray on my back because i couldn't handle the pain any longer.The clips have migrated per the x-rays.Drs i have told about this do not believe the symptoms are related to the clips and won't remove them.I want them removed.I have had to drop out of (b)(6) school due to the brain fog and lack of ability to concentrate.I now have heavy menstrual cycles, cramping and clots that i never had before.I want my life back.Please help.Thank you.(b)(6).My address is (b)(6).Fda safety report id # (b)(4).

• Brand Name: FILSHIE CLIPS
• Type of Device: LAPAROSCOPIC CONTRACEPTIVE TUBAL
• Manufacturer (Section D): FEMCARE - NIKOMED LTD.
• MDR Report Key: 9316637
• MDR Text Key: 166398905
• Report Number: MW5091024
• Device Sequence Number: 1
• Product Code: KNH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 11/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 59